Boston Scientific is discontinuing sales of its Imager II Angiographic Catheters after a manufacturing defect forced the medical device maker to pull the devices from the market. The company sent letters to customers last week instructing them to stop using or distributing all Imager II catheters immediately due to a risk that the tip can detach.
The Food and Drug Administration posted an early alert on Friday regarding the issue, noting that the problem can increase the risk of the catheter tip detaching. Boston Scientific reported two serious injuries associated with the problem as of July 16. The FDA alert states that the most common adverse event associated with tip detachment is a procedure delay to exchange for a new device. However, the problem could lead to serious complications, such as a life-threatening blockage from a device fragment obstructing blood flow in a vessel.
The medtech firm determined that the catheters were manufactured with reduced levels of stabilizing agents in the tip. This reduction could introduce the risk of the tip degrading or detaching. The Imager II catheters are single-use devices used to create images of areas of interest in the peripheral vasculature. They come in a variety of shapes and lengths.
The company said that no increase in tip detachment complaints has been identified with the affected lots, but it is still removing the devices from the market because they were manufactured outside of design specification. The company did not share more details about why it was discontinuing the product.
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Inventory verification steps
Boston Scientific decided earlier this year to discontinue the Imager II catheter, a company spokesperson wrote in an email. The device will no longer be available for procedures following the product removal. The company said healthcare facilities should verify using universal product numbers whether any of their inventory was affected. Devices taken out of the carton will have a different code than the outer packaging, which is important to note when searching for affected products.
The incident is a setback for a company that has faced scrutiny over product safety in recent months. Medical device recalls often expose the complex logistics of supply chains and the challenges manufacturers face in maintaining quality control across different production sites. When a device designed for precision imaging fails, the stakes extend beyond lost revenue to patient safety and procedural reliability.
Earlier this summer, Boston Scientific removed another catheter from the market over the risk of tip separation. That product was used as part of a stroke prevention system made by Silk Road Medical, which Boston Scientific acquired in 2024.
